Takeda wagers up to $2.2bn on AC Immune Alzheimer’s shot

Takeda has made a strong play for a stake in the Alzheimer’s disease market, paying $100 million upfront for an option on AC Immune’s amyloid-targeting immunotherapy.

The option fee could be followed by another up to $2.1 billion in potential milestones if Takeda takes global rights to the programme, currently headed by ACI-24.060, which is in a phase 1b/2 trial, with new data due in the next few weeks.

The ABATE study readout will see how well ACI-24.060 can reduce characteristic amyloid beta plaques in the brains of patients after six months of treatment with the drug, which is designed to stimulate an immune response against toxic forms of amyloid in order to clear them from the body.

If the drug reaches the market, AC Immune is also in line for mid-to-high teens percentages royalties on worldwide net sales.

The approach takes a different tack to other amyloid-targeting therapies for Alzheimer’s, including Eisai/Biogen’s approved therapy Leqembi (lecanemab) and Eli Lilly’s donanemab, which is currently under review by the FDA.

AC Immune chief executive Dr Andrea Pfeiffer said the ABATE study is a key ‘de-risking’ event for the programme and could be the last stage before it starts a registration trial.

“We believe the maximum impact of ACI-24.060 can best be realised by partnering with Takeda at this critical juncture in its development, which will help us move rapidly into phase 3,” she added.

Neuroscience is one of the cornerstones of Takeda’s R&D efforts, but Alzheimer’s hasn’t been a major feature of its pipeline, with just one candidate – Denali-partnered TAK-920 – reaching early stage clinical development before it was abandoned last year.

Sarah Sheikh, head of global development at Takeda and also in charge of its neuroscience division, said ACI-24.060 “leverages novel technology with the potential to offer patients a treatment with differentiated efficacy, safety, and ease of administration.”

The new alliance is a lift for AC Immune after Roche, its longstanding partner in Alzheimer’s, ended their collaboration in January after 18 years and handed back rights to two amyloid-targeting antibodies.

Along with ACI-24.060, it is also developing a tau protein-targeting immunotherapy for Alzheimer’s (ACI-35.030) with Johnson & Johnson, now in the phase 2b ReTain study, and a wholly-owned alpha-synuclein-targeting candidate (ACI-7104.056) in phase 2 for Parkinson’s disease.

Shares in AC Immune had shot up 28% at the time of writing.